Fontan CirculationPhase 1IMPROVE-FALDNCT06324396
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
A Phase 1 study testing Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) and Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years) in people with Fontan Circulation, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Fontan Circulation
- What is being tested?
- Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) and Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 8 years
- Status Post Fontan Completion
- Ability to provide informed permission-assent (<18 years) or consent (≥18 years)
- Fasting overnight (~8 hours)
Who cannot join
- Pregnancy
- Non-fasting
- Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
- Sildenafil and/or Pravastatin therapy within last 2 months
- History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
- Pharmacotherapy that interacts with Sildenafil (cytochrome P450 3A4 and P450 3A5 (CYP3A4/5) inducers/inhibitors) and/or Pravastatin (organic anion transporting polypeptide (OATP1B1) inducers/inhibitors)
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- Inability to swallow a tablet
- >5X the age-specific upper limit of normal for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total and conjugated bilirubin
- Diarrhea in the last 24 hours *History of solid organ transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Jonathan Wagner, DO
Jonathan Wagner, DO
About this study
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
- Conditions
- Fontan Circulation
- Being tested
- Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
- Keywords
- Fontan, FALD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)Drug
A single oral dose of sildenafil will be administered to all study subjects.
Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)Drug
A single oral dose of pravastatin will be administered to all study subjects.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Arm | Experimental | Assessment group will receive a single dose of oral sildenafil and oral pravastatin. Receives: Drug: Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg); Drug: Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sildenafil concentration as measured by area under the curve (AUC)
Area under the time-exposure curve (AUC 0-n) for sildenafil as determinants of the dose-exposure relationship.
Measured: 2 years
Pravastatin concentration as measured by area under the curve (AUC)
Area under the time-exposure curve (AUC 0-n) for pravastatin as determinants of the dose-exposure relationship.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fontan CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single center, open-label, prospective, investigation to quantify the effects of liver congestion and fibrosis has on hepatic statin transport (SA1) and response (SA2) in children, adolescents, and young adults with Fontan circulation.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jon Wagner, Children's Mercy Hospital Kansas City
- Investigators
- Jonathan Wagner, DO, Principal investigator, Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324396
- Sponsor's protocol ID
- STUDY00002974
- Other IDs
- 5T32HD069038
- Acronym
- IMPROVE-FALD
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
- ClinicalTrials.gov ID
- NCT06324396
- Acronym / sponsor ID
- IMPROVE-FALD / STUDY00002974
- Conditions
- Fontan Circulation
- Keywords
- Fontan, FALD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single center, open-label, prospective, investigation to quantify the effects of liver congestion and fibrosis has on hepatic statin transport (SA1) and response (SA2) in children, adolescents, and young adults with Fontan circulation.
| Arm | Type | Receives |
|---|---|---|
| Assessment Arm | Experimental | Drug: Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Drug: Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)Assessment group will receive a single dose of oral sildenafil and oral pravastatin. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- > 8 years
- Status Post Fontan Completion
- Ability to provide informed permission-assent (<18 years) or consent (≥18 years)
- Fasting overnight (~8 hours)
Key exclusion criteria (9 listed)
- Pregnancy
- Non-fasting
- Non-removable metal in body or where magnetic resonance imaging (MRI) is considered unsafe
- Sildenafil and/or Pravastatin therapy within last 2 months
- History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter Sildenafil and Pravastatin disposition (absorption, metabolism, distribution, or clearance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg)A single oral dose of sildenafil will be administered to all study subjects. | Drug | Assessment Arm |
| Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)A single oral dose of pravastatin will be administered to all study subjects. | Drug | Assessment Arm |
Primary outcome
Sildenafil concentration as measured by area under the curve (AUC)
Time frame: 2 years
Area under the time-exposure curve (AUC 0-n) for sildenafil as determinants of the dose-exposure relationship.
Pravastatin concentration as measured by area under the curve (AUC)
Time frame: 2 years
Area under the time-exposure curve (AUC 0-n) for pravastatin as determinants of the dose-exposure relationship.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Wagner, DO principal investigator
Children's Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) and Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years) in people with Fontan Circulation, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonthan Wagner, DO (816-731-7240, jbwagner@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sildenafil concentration as measured by area under the curve (AUC) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.